Collection of Data of Ceftobiprole Treated Patients: Comparison of Patients With and Without Certain Diseases

Rationale and background:

Ceftobiprole is a beta-lactam antibiotic with bactericidal activity against a broad spectrum of Gram-positive and Gram-negative bacteria, that was developed to treat patients with pneumonia both in a hospital or community setting. Clinical trials were conducted in adult immune-competent patients with normal or mild to moderate renal or hepatic function impairment. The clinical trial program completed to date has excluded patients with immune suppression and significant organ function impairment (hepatic or renal). The safety profile of ceftobiprole in these patient groups was recognized during the marketing authorization procedure as important missing information and the applicant committed to conduct a post authorization safety study.

A randomized Phase 3 study in the indication of acute bacterial skin and skin structure infections (ABSSSIs) is completed (NCT03137173), and a randomized Phase 3 study in the indication of S. aureus bacteremia is ongoing (NCT03138733). This retrospective chart review is conducted to further evaluate the safety profile of ceftobiprole in patient populations with specific risk factors.

Research question:

To estimate the proportion and the relative frequency of treatment-emergent adverse events (AEs) and adverse event of special interest will be assessed in patients treated with ceftobiprole and who have at least one of the following conditions:

* Impaired renal function * Impaired hepatic function * Immunosuppression

Treatment-emergent AEs are defined as events occurring after first study-drug administration, up to 28 days after the completion of treatment.

Adverse Events of Special Interest are the following;

* Hyponatraemia * Hepatobiliary disorders * Renal toxicity (including potential interactions with nephrotoxic drugs) * Coombs test (DAT) positivity + clinical evidence of haemolysis * Hypersensitivity reactions, including anaphylactic reactions * Pseudomembranous colitis / C. difficile colitis * Convulsions

The observed frequency of adverse events and adverse events of special interest in patients with the above risk factors will be compared to the frequency of these adverse events and adverse events of special interest in patients without these risk factors.